Case Clinical Trials Unit

病例临床试验单位

• 批准号: 10532725
• 负责人: JEFFREY M. JACOBSON
• 金额: $ 243.64万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-13 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10532725
• 关键词: AIDS clinical trial group; AIDS prevention; Address; Adult; Africa; African; Anti-Retroviral Agents; Area; Basic Science; Biopsy; Cerebrospinal Fluid; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Unit; Collaborations; Complement; Databases; Development; Disease; Doctor of Philosophy; Enrollment; Epidemic; Evaluation; Faculty; Funding; Grant; HIV; HIV Antibodies; HIV Infections; HIV Vaccine Trials Network; HIV prevention trial; HIV vaccine; HIV/TB; Health; Hepatitis; Hepatitis C Therapy; Immune response; Immunization; Immunocompetence; Immunologic Monitoring; Immunology; Immunotherapy; Inflammation; Infrastructure; International; Joints; Laboratories; Leadership; Leukapheresis; Life; Link; Logistics; Metabolic; Monitor; Monitoring Clinical Trials; National Institute of Allergy and Infectious Disease; Organ; PET/CT scan; Pathogenesis; Performance; Persons; Pharmaceutical Preparations; Phase; Population; Positioning Attribute; Predisposition; Prevention; Prevention Research; Productivity; Protocols documentation; Research; Research Personnel; Risk; Role; Site; Special Population; Tissue Sample; Translational Research; Tuberculosis; Uganda; United States National Institutes of Health; Universities; antiretroviral therapy; clinical center; clinical infrastructure; clinical research site; clinical trial analysis; determinants of treatment resistance; expectation; experience; high risk; improved; interest; lymph nodes; member; notch protein; novel; outreach program; participant enrollment; prevent; recruit; targeted treatment; translational research program; treatment trial; vaccination strategy; vaccine response; vaccine trial; volunteer

ABSTRACT The Case Clinical Trials Unit (CTU) comprises three highly productive clinical research sites: Case/UHC in Cleveland, the University of Cincinnati, and the Joint Clinical Research Center in Kampala. Each of these three sites is a top performing ACTG treatment trial site with excellent accruals, outstanding performance evaluations and major roles in the leadership of the network and it is scientific productivity. A key theme of this CTU is the close link of our clinical research portfolio with our basic and translational research programs. Thus, the three CRS sites of the Case CTU bring a comprehensive research plan to the enterprise. Led by faculty who are national and international leaders in their fields, these units are poised to make substantive contributions to each of the priority areas targeted by the ACTG: Inflammation/End Organ Disease, Antiretroviral Medications, HIV Eradication and Cure, Tuberculosis, and Hepatitis. The Case/UHC CRS has also been a productive member of the HVTN. The Case/UHC CRS has been a high- performing site in this network, having enrolled participants, including some from difficult-to-reach segments of the population, into multiple HVTN trials during this funding cycle. In some cases, enrollment has substantially exceeded expectations from the site. Additionally, Case CTU investigators are highly accomplished researchers who have extensive experience in the monitoring of immune responses form immunization, in evaluating diverse immunization strategies to enhance vaccine responsiveness, and in the use of vaccine responsiveness as a readout of immune competence. The University of Cincinnati CRS is a highly efficient, well-managed CRS that has been conducting clinical and translational research for the ACTG since 1987, and is the number 1 site by number of participants enrolled in the US. In addition to their extraordinary performance on enrollments, the site has extensive accumulated expertise in the metabolic complications of HIV, and is additionally a high-performing protocol-specific HPTN site. The JCRC is one of the top-performing international sites in the ACTG, and is the critical component in the contributions of the Case CTU to the tuberculosis agenda. It is also the site of the first hepatitis C treatment clinical trial in Africa, the ACTG A5360 protocol. The JCRC CRS has also previously demonstrated its ability to access large numbers of subjects in well-defined populations at high risk for HIV infection, having been the site of the first HIV vaccine trial in Africa, and can begin contributing to the HIV prevention networks immediately as well if selected as a site. Thus, the three CRS that comprise this CTU are positioned to provide sustained leadership and contribution to the treatment and prevention agenda of the NIAID Networks.

抽象的 病例临床试验单元（CTU）包括三个高生产力的临床研究地点：案例/UHC 克利夫兰，辛辛那提大学和坎帕拉的联合临床研究中心。每个 三个站点是表现出色的ACTG治疗试验地点，具有出色的应计，出色的性能 评估和主要角色在网络领导中，这是科学生产力。一个关键主题 该CTU是我们的临床研究组合与我们的基本和转化研究的紧密联系 程序。因此，案件的三个CRS站点CTU为该计划带来了全面的研究计划 企业。这些单位由教师是国家和国际领导人的领导 为ACTG针对的每个优先领域做出实质性贡献：炎症/结束 器官疾病，抗逆转录病毒药物，消除HIV和治愈，结核病和肝炎。这 CASE/UHC CRS也是HVTN的生产成员。案例/uhc crs是高度 在此网络中执行网站，已入学，包括一些难以到达的细分市场 在这个资金周期中，人口中的多个HVTN试验。在某些情况下，注册有 对网站的预期大大超出了期望。此外，案例CTU调查人员很高 在监测免疫反应形式方面具有丰富经验的有成就的研究人员 免疫，评估各种免疫策略以增强疫苗反应性，并在 将疫苗反应用作免疫能力的读数。辛辛那提大学CRS 是一项高效，管理良好的CR，一直在进行临床和转化研究 自1987年以来，ACTG是由美国入学的参与者数量的1号站点。除了他们 该网站在入学率上表现出色，在代谢方面具有广泛的累积专业知识 艾滋病毒的并发症，另外是高性能的特定于方案特异性的HPTN部位。 JCRC是一个 ACTG中表现最佳的国际遗址，是贡献的关键组成部分 结核病议程的CTU。它也是第一次丙型肝炎治疗临床试验的地点 非洲，ACTG A5360协议。 JCRC CRS以前还证明了其访问能力 艾滋病毒感染风险高的人群中的大量受试者已成为现场 非洲的第一次HIV疫苗试验，可以立即开始为HIV预防网络做出贡献 如果选择为站点。因此，构成该CTU的三个CR可以提供持续的 NIAID网络的治疗和预防议程的领导和贡献。